Artificial sphincter system and method

ABSTRACT

The present invention provides an artificial sphincter employing an easily controlled electro-mechanical pump system. The artificial sphincter includes an inflatable cuff, a control pump fluidly coupled to the inflatable cuff, and an electro-mechanical pump system. The inflatable cuff is adapted to surround a urethra or rectum of the patient to facilitate continence. An inflation element or balloon can be included to further control pressure to the cuff.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of, and claims priority to, U.S.patent application Ser. No. 13/328,856, filed on Dec. 16, 2011, entitled“ARTIFICIAL SPHINCTER SYSTEM AND METHOD”, which, in turn, claimspriority to U.S. Patent Application No. 61/423,777, filed on Dec. 16,2010, entitled “ARTIFICIAL SPHINCTER SYSTEM AND METHOD”, the disclosuresof which are incorporated by reference herein in their entirety.

FIELD OF THE INVENTION

The present invention relates generally to treatment of pelvic disordersand, more particularly, to an electro-mechanical artificial urinarysphincter system activated by a remote control, implanted switch or likedevice.

BACKGROUND OF THE INVENTION

Incontinence is an affliction that prevents a patient from controllingwaste elimination functions. As one might expect, this condition can bequite debilitating and embarrassing and may severely limit the patient'sactivities.

Various techniques exist for treating incontinence in patients. One suchtechnique is surgical implantation of an artificial sphincter. One formof artificial sphincter includes an appropriately sized inflatable cuffthat is positioned around either the urethra or the rectum, dependingupon the nature of the incontinence. A control pump is fluidly coupledto the cuff and to a pressure-regulating balloon, both of which arepositioned within the body of the patient. Under normal conditions, thecuff is inflated which causes a compression of the urethra or therectum, thus preventing unintentional discharge. When so desired, thepatient manually actuates the control pump. Fluid is then withdrawn fromthe cuff and forced into the pressure-regulating balloon. As thisoccurs, the cuff relaxes allowing the urethra or rectum to expand andopen. At this point, normal waste elimination functions are permitted.The pressure-regulating balloon contains a volume of fluid that ismaintained at a relatively high pressure. The control pump is providedwith a fluid resistor that allows pressurized fluid to slowly return tothe cuff causing it to automatically re-inflate.

While manually-operated pump systems in conventional artificialsphincters can be useful, the patient must grasp a pump that isimplanted in his scrotum and squeeze the pump bulb several times inorder to void. The process may be considered burdensome and cause thepatient to feel self conscious or conspicuous in public. In addition,there may be issues with over-pumping, as well as inefficienciesassociated with imprecise manual pump volumes. Further, it is possiblethat urethral tissue health can be compromised by continuous cuffpressure.

SUMMARY OF THE INVENTION

The present invention provides an artificial sphincter employing aneasily controlled electro-mechanical pump system. The artificialsphincter includes an inflatable cuff, a control pump coupled to theinflatable cuff, and an electro-mechanical pump actuator coupled to thecontrol pump. A balloon or inflation element can be included in variousembodiments. The inflatable cuff is adapted to surround a urethra orrectum of the patient to control continence. Sensors, electronic controldevices and remote actuation devices can be included with embodiments ofthe present invention. One or more valves can be included withembodiments to selectively control the fluid displacement and path.

Various embodiments can include a chamber system for the pump, includingone or more actuators and one or more internal seal members to displacefluid within the chamber to control inflation or deflation of the cuff.Other embodiments can include an inflation element (e.g.,pressure-regulating balloon) integrated with the pump device or systemto control fluid displacement.

Certain embodiments can include a peristaltic or roller pump system, ora “squiggle” pump system, adapted for use with the artificial sphinctersystem to control fluid flow and distribution to and from the cuff andpump.

Still other embodiments can include a centrifugal or vane pump system tocontrol inflation and deflation of the cuff.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an implanted conventional artificial sphincter system.

FIG. 2 shows an exemplary electro-mechanical artificial sphincter systemimplanted in accordance with embodiments of the present invention.

FIGS. 3-9 shows schematic views of portions of a linear actuatedelectromechanical sphincter and pump systems in accordance withembodiments of the present invention.

FIGS. 10-14 show schematic views of portions of a linear actuatedelectromechanical sphincter and pump system having an integratedpressure-regulating inflation element in accordance with embodiments ofthe present invention.

FIGS. 15-18 show schematic views of an electro-mechanical sphincter andpump system having a pivoting member in accordance with embodiments ofthe present invention.

FIG. 19 shows a schematic view of a spring-driven override or releasemechanism in accordance with embodiments of the present invention.

FIGS. 20-25 show schematic views of peristaltic or roller pump devicesfor electro-mechanical sphincter systems in accordance with embodimentsof the present invention.

FIGS. 26-28 show schematic views of centrifugal or vane pump devices forelectro-mechanical sphincter systems in accordance with embodiments ofthe present invention.

FIGS. 29-33 show schematic views of a ‘squiggle’ motor pump system forelectromechanical sphincter systems in accordance with embodiments ofthe present invention.

FIGS. 34A and 34B show schematic views of a portion of anelectro-mechanical sphincter and pump system in accordance with variousexample embodiments.

FIGS. 35A and 35B show schematic views of a portion of anelectro-mechanical sphincter and pump system in accordance with variousexample embodiments.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Referring generally to FIGS. 2-33, embodiments of the present inventioncan include an artificial sphincter system 10 adapted to controlincontinence in the patient. In general, the cuff is attached to orwraps around a portion of the patient's urethra (or rectum) to controlthe sphinctering function of the particular anatomy.

The artificial urinary sphincter (“AUS”) system 10 includes anelectro-mechanical control pump 20 attached to a pressure-regulatinginflation balloon or element 24. The inflation element 24 is likewise inoperative fluid communication with the cuff 30 via one or more tubes orconduits 32, chambers, valves or similar structures. The variousconduits 32 can be separable at connectors to facilitate theimplantation during a surgical procedure. The inflation element 24 isconstructed of polymer material that is capable of elastic deformationto reduce fluid volume within the inflation element 24 and push fluidout of the element 24 and into the cuff 30. However, the material of theelement 24 can be biased or include a shape memory construct adapted togenerally maintain the element 24 in its expanded state with arelatively constant fluid volume and pressure. In certain embodiments,this constant level of pressure exerted from the element 24 to the cuff30 will keep the cuff at a desired inflated state when open fluidcommunication is provided between the element 24 and the cuff 30. Thisis largely due to the fact that only a small level of fluid displacementis required to inflate or deflate the cuff 30. Further, embodiments ofthe system 10 provide for implanting or placing the element 24 in theabdominal space. As such, stress events at this abdominal region (e.g.,short increases in abdominal pressure) can be transmitted to measurablydeform the element 24 to push fluid flow through to the cuff 30 to atleast temporarily increase cuff 30 pressure to improve protectionagainst stress incontinence. If the element 24 is located within thepump 20 or pump housing 21, the cuff 30 pressure can be dynamicallycontrolled by the electronics, sensors and devices as disclosed herein.The sensors can monitor or ‘listen’ for stress events such as suddenmovement, spike in abdominal pressure, neural or muscular electricalactivity (e.g., reading electrical signals from leads like in an EMGdevice), and modulate device pressure to ensure the cuff 30 is at theoptimal pressure at a given time or event, whether it is to void or topromote continence. The resting cuff 30 pressure can also be regulatedby the electronics included with the pump 20 or pump housing 21. Forinstance, extra fluid aspirated from the cuff 30 can be stored in apassive fluid reservoir, such as the space inside a syringe-type pumpsystem 20.

The cuff 30 may be formed from silicone, which has proven to be areliable and medically safe material compatible with human tissue. Thecuff 30 may also be formed from other suitably flexible biocompatiblematerials. The cuff 30 is positioned around the urethra within thepatient's abdomen. Embodiments of the present invention can include, inwhole or in part, the various components, devices, structures andtechniques disclosed in U.S. Patent Publication Nos. 2010/0160716,2010/0010530, 2006/0083848, U.S. Pat. Nos. 6,460,262, 7,011,622,7,681,518, and PCT International Publication Nos. WO2001/060283,WO1993/004727, WO2006/041861 and WO2009/094431. Each of the above-listedpatents and publications are incorporated herein by reference in theirentireties. Further, the various components, devices, structures andtechniques disclosed herein can be employed with, in whole or in part,known AMS 700 or AMS 800 sphincter devices and systems sold by AmericanMedical Systems of Minnetonka, Minn.

Unlike pump systems used in conventional artificial sphincter systems,the system 10 and electro-mechanical pump 20 of the present inventioncan move fluid bidirectionally, automatically, or remotely withoutmanual pumping. The flow can remain generally inactive or latched, andoccasionally move a small but consistent volume. The flow can thenreverse. Further, embodiments can include a housing 21 that comprisesthe pump 20 components, such as the motor and drive mechanisms, as wellas the power (e.g., battery) and other electronic and mechanicalcomponents and elements disclosed herein.

Control over the pumps 20 in various embodiments can be facilitatedremotely, by remotely triggering a switch and without manualmanipulation like those required in conventional devices and systems.Namely, the pump 20 and motor can include a switch that is triggered toactivate the motor. The activation can be used to trigger the pump todeflate the cuff 30 in certain embodiments to facilitate voiding, torelease the cuff during sleep, etc. Other embodiments can use remotetriggering to start the pump 20 to inflate or increase pressure from thecuff 30. The remote triggering of the pump 20, or other components ofthe system 10, can be included with portable small devices, such aswatches, bands, key fobs, transmitter cases, and the like remoteactuation or triggering devices. The remotes can communicate wirelesslywith the system 10 controllers or electronics.

Embodiments of the pump 20 or housing 21 can include electric control orprocessing chips or electronics controllers in communication with thepump 20 and adapted to control the pump 20 and receive and storefeedback data from the human body or the system 10 for later processing,or retrieval by a user or physician. Sensors, including those disclosedherein, can be included to automatically trigger the pump 20, e.g., todeflate or inflate the cuff 30 at proper moments or under certain stressevents. One area where this is useful, is in detecting a desire to void.When a person wants to void, the pelvic floor and urethral sphinctermuscles relax while the detruser (bladder muscle) contracts. Forinstance, one or more sensors can monitor electrical activity of thebladder or sphincter, or the pressure of the bladder and the abdomen, orother relevant inputs (e.g., an accelerometer device to gauge patientmovement) to detect attempts by the patient to void such that the pump20 can automatically deflate the cuff 30 at this appropriate time.Further, the controller electronics for the system 10, or pump 20, canbe programmed and re-programmed (software or programmable chips) todeflate at a set time (e.g., night), or adjust cuff 30 pressurethroughout the day to a schedule (e.g., increase cuff 30 pressure duringknown strenuous activity or times), or based on input from the sensors,to optimize continence.

Various component and chamber (e.g., syringe type) configurations of anembodiment of the system 10 and pump 20 are depicted in FIGS. 3-14. Thepump 20 can include a chamber housing 40 and an actuator 42 (e.g.,linearly driven) operably coupled to the chamber 40. The internal spaceof the chamber 40 is adapted to hold and displace fluid, e.g., liquid orgas. An input 44 to the chamber 40 is operably coupled with the actuator42 and an output port 46 (e.g., distal to the actuator 42) providesconnectivity to the cuff 30. Further within the chamber 40 is a fluiddisplacement member 48 operably connected to the actuator 42, such asvia a shaft member 43, such that driving movement of the actuator 42 inand out of the chamber 40, relative to the displacement member 48,effects fluid displacement within the chamber 40. In certainembodiments, the member 48 is generally sealingly contacting inner wallsof the chamber 40 such that a first chamber portion 50 is provided infront of the member 48, and a second chamber portion 52 is providedbehind the member 48.

In certain embodiments, the member 48 is a moving piston-like orplunger-like (e.g., syringe) member adapted to travel, even if only alimited distance, within the chamber 40 via driving of the actuationmember 48. In such cases, when the actuator 42 is driven into thechamber 40, the fluid present in the front chamber portion 50 will bedisplaced by the member 48 so that an amount of fluid will exit out theoutput port 46 to correspondingly inflate the cuff 30, to increase orstabilize continence. Similarly, retracting the actuator 42 and themember 48 will correspondingly increase the fluid in the first chamberportion 50, thereby reducing the fluid in the second chamber portion 52and forcing excess fluid that was in that second chamber space to exitout a reservoir port 54 and into a balloon, pouch, chamber or likedevice or feature in communication with the second chamber portion 52 ofthe chamber 40. Retracting the actuator 42 will correspondingly deflatethe cuff 30 to permit the patient to void.

For each embodiment disclosed herein, the actuator 42, or a portion ofthe member 48, can be biased to automatically, or selectively, return tothe continence position where the cuff 30 is sufficiently inflated.Springs, shape memory materials (e.g., membrane 48), or even anautomatic return motor or driver in the actuator can achieve this returnto an inflatable home position for the pump 20 and cuff 30.

In various embodiments, as shown in FIGS. 3-7, the member 48 is amembrane member 48. The membrane member 48 is generally flexible, atleast in part and can be substantially stationary with respect to linearmovement within the chamber 40. Instead of driving back and forth in thechamber 40, the membrane member 48 deforms by expanding, bulging orcontracting to displace fluid around it. As described herein, thisdisplacement of fluid in the chamber portions 50, 52 willcorrespondingly move fluid in and out of the output port 46 and/or thereservoir port 54 to facilitate inflating or deflating the cuff 30.Again, a large level of fluid displacement is not required to drivefluid and pressure changes (e.g., through the output) to inflate ordeflate the cuff 30 in the system 10, so this deformation of themembrane 48 can cause the desirable amount of fluid displacement. Themembrane can be a cone or domed shaped member (FIGS. 3, 7) or agenerally thin and flat member (FIGS. 4-6). FIGS. 4-6 depict the thinmembrane 48 deforming outward (FIG. 5) from an initial rest position(FIG. 4) to displace fluid to inflate the cuff 30, and deforming inward(FIG. 6) to deflate the cuff 30, all according to the drive of theactuator 42 coupled to the membrane 40, or a portion thereof. In certainembodiments included within FIG. 3, the element 24 does not need to beincluded to maintain pressure in the cuff 30, but could be included asdesired.

Various embodiment or the pump 20 itself can include a pump or chamberbody portion 41 adapted to be collapsible, and expandable, to controlfluid to and from the cuff 30. Such embodiments would not require aseparate member 48 sealed within a chamber 40 as the chamber, or otherportion of the pump 20, would essentially serve as the fluid transfermechanism due to its construct. For instance, as shown in FIGS. 34A and34B, the body 41 is constructed as a bellow or flexible wallconfiguration such that movement of the body 41 inward compresses thebody 41 (FIG. 34B) to expel fluid through the port 46 and to the cuff 30for inflation, or pressure increase. Likewise, retracting or pullingback on the body 41 (FIG. 34A) can draw fluid into the body 41 and outof the cuff 30 to facilitate deflation or emptying of the cuff 30. FIG.34A can represent the body 41 in a neutral or resting home position.FIGS. 35A and 35B show another embodiment of such a body portion 41having an internal bellow or like structure 41 a adapted to selectivelyexpand and contract with the pump 20 to drive fluid out the port 46 intothe cuff 30, or from the cuff 30 back in.

The embodiments of FIGS. 7-9 are similar to those of FIGS. 3-6, exceptthey can include a 3-way valve 59 at the distal end of the pump 20 andan inflatable and deflatable member or tube element 60 (e.g., ratherthan a separate reservoir) wrapped around the chamber 40 proximate theactuator 42. The 3-way valve 59 is in operable fluid communication withthe port 46 of the chamber 40, and the element 24 and the cuff 30 via aconduit 62 (or 32), or like fluid transfer member. Again, the member 48can be a flexible membrane adapted to deform to displace fluid withinthe chamber 40, and chamber portions 50, 52 in particular, to controlinflation and deflation of the cuff 30. FIG. 8 depicts a schematicrepresentation of the valve 59 in an open position to permit open fluidcommunication between the element 24 and the cuff 30 along the conduits62 and through the valve 59. The element 24 can maintain a constantinflating pressure for the cuff 30 in this operational position. FIG. 9shows a schematic representation of the valve 59 triggered via a valveactuator 59 a to provide open fluid communication between the cuff 30and the pump 20 (not the element 24) to actively control the inflationand deflation of the cuff 30 via operation of the membrane 48 and thedisclosed fluid displacement procedures. Like other triggering oractuation features and actions of embodiments of the present inventionand system 10, the valve 59 can be triggered remotely via an electricsignal, magnetic field, sensor activation, and the like.

Further, the actuators 42 disclosed herein can be driven in a myriad ofways, including, for example, linearly with an unwound electrical motor,a threaded power screw, a crank arm, or via like electric orelectro-mechanical motor or driving means.

Various embodiments of the system 10 can include configurations wherethe pressure-regulating element 24 and pump 20 devices are combined orintegrated, as shown in FIGS. 10-14. As such, a portion 70 of theelement 24 extends into the chamber 40 of the pump 20 and into operablecommunication with the actuator 42. The actuator 42 can disrupt orotherwise move fluid within or out of the element 24. The element 24 isin operable fluid communication with the cuff 30 via one or more tubingor conduit elements 72. The elements 72 can also be provided in operablefluid communication with the inner space of the chamber 40, with a 2-wayor like valve 74 included along a portion of the conduit 72 length tocontrol fluid flow between the element 24, the cuff 30 and the chamber40. Such a configuration is shown in one embodiment as a tee-connection76.

As shown in FIG. 11, the active continence configuration for this system10 has the valve 74 open to maintain the pressure in the cuff 30 at aninflated state. When the patient or user wishes to void, they begin theprocess by actuating the valve 74 (e.g., remotely or via sensors) toclose the valve 74 such that fluid from the cuff 30 is directed into thechamber 40 to displace the element 24 and at least partially deflate thecuff 30, as shown in FIG. 12. Upon reaching a predefined or balanceconfiguration with the valve 74 closed and increased fluid in thechamber 40, the actuator 42 is generally configured to be fixed inposition until the voiding is complete (FIG. 13). Upon completion of thevoiding, the valve 74 is opened and the actuator 42 is initiated todrive downward away from the pump 20 to bring the element 24configuration into its continence position with fluid flow and pressureregulation complete between the element 24 and the inflated cuff 30.

FIGS. 15-18 depict another embodiment of the system 10. This embodimentcan include a single-stroke or like pump 20. While any of theembodiments disclosed herein can be provided in a small or thin box-likeconfiguration to house the pump, chamber, conduits, electronics, etc.,this embodiment is particularly shown with such a configuration. Aportion 80 (e.g., rounded corner portion) can include the pump 20structures and components, including a fluid chamber 82. The otherportion 81 of the system 10 can house the battery and electronics (e.g.,for remote actuation, motor driving power, etc.).

An actuator 84 (e.g., linear) can drive a member or pivoting wiper arm86 (e.g., angular). The arm 86 can be rubberized, or of a likeconstruct, and in sealing contact with various interior walls of thechamber 82. The actuator 84 is connected to the arm 86 at joint 88. Thechamber 82 can include a cuff port 90 providing connection and operablefluid communication between the chamber 82 and the cuff 30. The chamber82 can further include a balloon port 92 providing connection andoperable fluid communication between the chamber 82 and the element 24.In the normal continence state, as shown in FIG. 16, the arm 86 isgenerally to one side of the chamber 82 such that free fluid flow ispermitted between the element 24, the interior space of the chamber 82and the cuff 30, to maintain an inflated cuff 30. To void, the actuator84 is initiated to drive the arm 86 back into the chamber 82 space to atleast substantially block off the fluid flow from the cuff 30 to theelement 24, pulling fluid from the cuff 30 and pushing fluid into theelement 24, thereby deflating the cuff 30 and permitting voiding, asshown in FIG. 17. In the deactivated or voiding configuration of FIG.18, with the cuff 30 empty or deflated, the arm 86 has been pivoted tothe side of the chamber 82 to sealingly block the port 92. A solenoid orother valve device can be employed to keep the fluid path between thechamber 82 and the element 24 closed for longer term deactivations. Toreturn to the continence state, the actuator 84 drives the arm 86 backto the opposing side of the chamber 82 to permit open fluid flow betweenthe cuff 30, the chamber 82 and the element 24, thereby inflating thecuff 30. Again, like the other embodiments, this mechanism can bepowered by a power source, such as a battery, and actuated remotely bythe user or patient.

It is noted that any of the embodiments disclosed herein driven orcontrolled by electronics and power (e.g., battery), can include asafety or override mechanism to permit deflation of the cuff 30 even iftheir has been a failure or problem with any of the electronics, poweror electro-mechanical structures or components. As shown in FIG. 19, aspring-driven mechanism 100 is provided, normally under tension,connected to any of the actuators (e.g., 42, 84) of the system 10 andcapable of being triggered by an external safety magnet. When the magnetis held on the skin near the system 10, the magnetic field will actuatea mechanism release 102. As such, energy stored in a spring 104 of themechanism 100 will be released to correspondingly release the normalsystem 10 actuator, thereby sucking or pulling fluid from the cuff 30.The spring 104 can be a normal spring device, or can be provided inother constructs, such as a flexible chamber walls, coated materials,etc. Further, other methods and devices for providing an override toprovide an emergency release of the actuators or other structures todeflate or empty the cuff 30 are envisioned as well.

Various embodiments, as shown in FIGS. 20-25, can include a peristalticor roller pump system 110 adapted for use with the systems 10. Ingeneral, the roller pump system 110 includes a roller 112, a rollershaft 114, spring loaded portions 116, and a tube channel 118. FIG. 21shows the spring loading of the rollers 112 accomplished by a formedsheet metal spring, with the rollers 112 in a groove on a disk 111 toallow for relative motion, while still providing the bias of the spring116 such that the roller is biased down into the tube channel 118. Thisconfiguration provides tube or conduit 120 occlusion, with the tube orconduit 120 running in a controlled depth on the ends of thespring-loaded rollers 112 in the tube channel 118, to control the amountof tube compression and corresponding occlusion. This pump system 110can be self-contained to include a housing for the battery, controlelectronics, return reservoir 115 (or element 24), etc. The system 110will include communication between the pump and the cuff 30, as well asthe element 24 or return fluid reservoir 115. In general, the roller 112can compress the tube or conduit 120 providing fluid to the cuff 30,extending within the tube channel 118, to control deflation of the cuff30.

Embodiments of the pump system 110 shown in FIGS. 22-23 can include a3-way valve 122 and a spring-loaded reservoir 115. The valve 122 isprovided at the juncture of the pump 110, the reservoir 115 and theconduit 120 running to the cuff 30. The valve 122 selectively connectsthe cuff 30 to the pump 110 (fluid communication) to evacuate or deflatethe cuff 30. To refill the cuff 30, the valve 122 provides fluidcommunication between the reservoir 115 and the cuff 30. Compressionsprings 119 in the reservoir portion 115 for this embodiment can biasthe bladder 117 of the reservoir portion 115 such that it is generallypushing fluid to the cuff 30 when the valve 122 permits opencommunication between the reservoir 115 and the cuff 30.

FIG. 24 shows an embodiment of the pump system 110 not having a valve orbladder (reservoir 115 or element 24). Instead, fluid is stored in thetubing 120 and the pump motor is reversed (uncompressing tubing 120) torefill the cuff 30. So voiding is enabled with compression on the tubing(by pump and roller) to evacuate the cuff 30. When a continence state isdesired, the compression is released with reversal of the pump motor toenable fluid flow through the tubing 120 to again inflate the cuff 30.Alternative embodiments could put an element 24 (shown in phantom lines)in line with the cuff to provide constant fluid pressure or balance tothe cuff 30. A vent and filter device 124 can be included incommunication with the pump 110 to assist in controlling pressure andfluid within this system.

This roller pump system 110, like others disclosed herein, can includean override or bypass system or method to evacuate or deflate the cuff30. As shown in FIG. 25, a bypass activated valve 130 (e.g., capable ofbeing magnetically activated, externally activated) can be included incommunication between the reservoir portion 115 and the cuff 30 and/orthe tubing 120 to the cuff 30. The reservoir 115 is maintained in anegative pressure state such that activating the valve correspondinglybypasses the pump motor 110 to empty or deflate the cuff 30.

Various embodiments of the system 10 can include a centrifugal or vanepump system 140 to control inflation and deflation of the cuff 30, asshown in FIGS. 26-28. This pump system 140 can include a brushless DCmotor 142 driving a rotating impeller 144 to transfer fluid out of thecuff 30. The pump 140 is spun up or initiated to create positivepressure in the cuff 30. The reservoir or element 24 is generally undernegative pressure and can therefore be used to evacuate the cuff 30.Alternatively, the element 24, or other reservoir bladder or portions,can be included to pressurize or refill the cuff 30 similar to otherembodiments disclosed herein.

A 2-way valve 146 can be included along tubing or conduit 145 (extendingfluid communication to cuff 30) to trap pressure in the cuff 30.Further, a 3-way valve 148 can be included to selectively control fluidcommunication of conduits or lines between the pump 140, the reservoir24 and the cuff 30. A pressure sensor 148 can be included as well totrigger or control the various components.

An embodiment of the pump system 140 for the invention 10 is provided inFIG. 27, including a reservoir bladder 149, and an element 24 in-linewith the cuff 30 such that the reservoir 24 is under negative pressureto keep the cuff 30 inflated, or to refill the cuff 30. A 2-way valve147 can be included to provide control over the fluid communication ofthe reservoir 149 and the motor 140, or cuff 30. Again, a pressuresensor can be included to provide additional control and detection ofthe fluid system.

In certain embodiments of the pump system 140, the pump impeller 144 canbe magnetically coupled to the motor. As depicted, a magnet element 150is positioned between the motor 152 and the magnet impeller 144 (e.g.,magnet and impeller).

With any of the pump systems 140, the impeller 144 can be run in reverseto correspondingly reverse the fluid flow (e.g., inflate or deflate thecuff 30).

Embodiments of the system 10 are shown in FIGS. 29-33 including a“squiggle motor” pump system 160. Embodiments of this pump system 160can implement pumps, mini- or mico-pumps or other “squiggle motor”systems or components sold by New Scale Technologies of Victor, N.Y.This system 160 for the present embodiment can be particularly useful inthose systems disclosed herein having linear actuators for the pumpsystems. The system 160 can include a motor 162, a roller or bearingmechanism 164 and a tubing or conduit 166. Again, the tubing 166provides fluid communication between the system 160 and the cuff 30. Thesystem 160 has the advantage of not having moving seals, and beingself-locking so that the motor does not need power to maintain pressurealong the tubing 166. The motor 162 drives the bearing 164 along thetubing 166 to displace fluid relative to the cuff 30. For instance, thecompression of the bearing 164 on the tubing 166 eventually cuts off ordisrupts pressure to the cuff 30, thereby clearing or emptying the cuff30. When fluid communication is not disrupted between the cuff 30 andthe element 24, the cuff 30 remains under pressure and inflated at leastpartially due to the element 24. FIGS. 31-33 depict the operation of thesquiggle motor pump system 160 engaging the tubing 166 (FIG. 31),compressing or pushing on the tubing 166 to close off (e.g., closingi.d. of tubing 166) the fluid flow (FIG. 32) to the cuff 30. Thisisolates the cuff 30 from the element 24. Once the roller clears (e.g.,a cam surface) it returns or pops up so that the tubing 166 is again inopen fluid communication with the cuff 30, and the element 24 canmaintain the pressure of the inflated cuff 30. At the end of theprocess, the roller can automatically retract back to its startingposition.

All patents, patent applications, and publications cited herein arehereby incorporated by reference in their entirety as if individuallyincorporated, and include those references incorporated within theidentified patents, patent applications and publications.

Obviously, numerous modifications and variations of the presentinvention are possible in light of the teachings herein. It is thereforeto be understood that within the scope of the appended claims, theinvention may be practiced other than as specifically described herein.

What is claimed is:
 1. An artificial sphincter system, comprising: anadjustable cuff adapted to apply pressure to a bladder neck or a urethrato promote continence; a pump configured for inflation or deflation ofthe cuff, the pump including; a fluid chamber in fluid communicationwith the cuff; a flexible membrane disposed within the fluid chamber,the flexible membrane dividing the fluid chamber into a first portionand a second portion, the flexible membrane being cone or dome shaped;and an actuator operatively coupled to the flexible membrane; and avalve in fluid communication with the fluid chamber, the cuff, and aninflation element, wherein the flexible membrane is disposed between thevalve and the actuator, wherein when the valve is in a first position,the inflation element and the cuff are in fluid communication, whereinwhen the valve is in a second position, the fluid chamber and the cuffare in fluid communication.
 2. The system of claim 1, wherein the pumpfurther includes a motor adapted for remote actuation.
 3. The system ofclaim 1, wherein the flexible membrane is configured to deform uponactuation of the pump to displace fluid within the fluid chamber.
 4. Thesystem of claim 1, wherein the inflation element is configured toreceive excess fluid during deflation of the cuff.
 5. The system ofclaim 1, further including a pump housing to house at least the pump. 6.The system of claim 1, wherein the pump is linearly driven.
 7. Thesystem of claim 1, wherein the flexible membrane is coupled to asidewall of the fluid chamber.